OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women

OneDoc Picopulse™ is a radiopulse technology beauty grade device invented for treating melasma.

Study Overview

• Status: Completed
• Conditions: Skin Diseases; Melanoma (Skin); Skin Disorder
• Intervention / Treatment: Device: OneDoc Picopulse

Detailed Description

This is a new attempt to evaluate the effectiveness of OneDoc PicopulseTM in treating melasma among women of childbearing age in Klang Valley, Malaysia. This pilot feasibility study protocol is to access feasibility of the OneDoc Picopulse™ in the future definitive trial. The findings of this study would justify OneDoc Picopulse™ as one of the promising alternative treatment for melasma.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yang Mooi Lim, PhD; Phone Number: 60390860288; Email: ymlim@utar.edu.my
• Study Contact Backup: Name: Chai Nien Foo, PhD; Phone Number: 60390860288; Email: foocn@utar.edu.my

Study Locations

• Malaysia
  • Cheras, Malaysia
    • OneDoc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women presenting dermal melasma with Fritzpatrick skin type III to V
• Malaysian citizen
• Agreed to participate
• Provide informed consent

Exclusion Criteria:

• Patients who had a laser procedure, phototherapy therapy, peel, oral therapy, topical treatment or used lightening creams in the treatment area within the past 6 months.
• Patients with pregnancy, lactating, active dermatitis, had a history of immunosuppression/immune deficiency disorders
• Patients who photosensitivity or taking drugs known to induce photosensitivity,
• Patients that have been exposed to severe sun exposure, having severe epidermal injury, allergy and sensitivity
• Patients who could not attend follow-up treatments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Eligible patients will receive ten picopulse treatments for bi-monthly.	Device: OneDoc Picopulse; Eligible patients will proceed to receive skin cleansing prior to OneDoc Picopulse treatment. After the cleansing, the patients will receive OneDoc Picopulse treatment for 15 mins. Patients will receive ten picopulse treatments for bi-monthly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the treatment	Short Assessment of Patient Satisfaction (SAPS) questionnaire with additional Qualitative data collection; The score range for SAPS is from 0 (extremely dissatisfied) to 28 (extremely satisfied)	One month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the recruitment and measurement tools	Number of patients referred from OneDoc and eligible for screening; Number of patients recruited; Follow-up response rates (2 weeks and 1 month follow-ups)	Pre-treatment, two weeks and one month
Treatment adherence	Number of treatments attended	five months
Melasma	Melasma Severity Index (MSI) and by observation; MSI score ranges from 0 (no melasma) to 64 (severe melasma)	Through study completion, an average of 24 weeks
Quality of life of patients	Melasma Quality of Life Scale (MELASQOL) score ranges from 10 to 70; Higher the score, worse is the quality of life	Pre-treatment, two weeks and one month post-treatment
Safety evaluation	Incidence and severity of side effects caused by treatments	immediately after and before each subsequent treatment

Collaborators and Investigators

• Sponsor: Universiti Tunku Abdul Rahman
• Investigators: Principal Investigator: Yang Mooi Lim, PhD, Universiti Tunku Abdul Rahman

Publications and helpful links

General Publications

• Amini F, Thazin Oo NM, Okechukwu PN, Seghayat MS, Ng ESC. Polymorphisms in P53 and VEGFA genes in different subtypes of periorbital hyperpigmentation in a Malaysian Chinese population. Australas J Dermatol. 2019 May;60(2):e99-e104. doi: 10.1111/ajd.12918. Epub 2018 Sep 14.
• Chalermchai T, Rummaneethorn P. Effects of a fractional picosecond 1,064 nm laser for the treatment of dermal and mixed type melasma. J Cosmet Laser Ther. 2018 Jun;20(3):134-139. doi: 10.1080/14764172.2017.1376098. Epub 2017 Dec 4.
• Labadie JG, Krunic AL. Long pulsed dye laser with a back-to-back double-pulse technique and compression for the treatment of epidermal pigmented lesions. Lasers Surg Med. 2019 Feb;51(2):136-140. doi: 10.1002/lsm.23009. Epub 2018 Oct 15.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Melasma; Skin treatment; Picopulse; Malaysian women
• Additional Relevant MeSH Terms: Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Melanosis
• Other Study ID Numbers: UTAR-45-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No